Comparison · NCT02195479-sae
Velcade, Melphalan and Prednisone (VMP) vs Daratumumab, Velcade, Melphalan and Prednisone (D-VMP): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Velcade, Melphalan and Prednisone (VMP) vs Daratumumab, Velcade, Melphalan and Prednisone (D-VMP): serious adverse events. Trial comparisons, record NCT02195479-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02195479-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.331 | 0.284 | 0.381 | wilson | |
| Risk in group 2 | 0.538 | 0.485 | 0.589 | wilson | |
| Risk difference, group 1 minus group 2 | -0.207 | -0.277 | -0.134 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.615 | 0.515 | 0.734 | log | |
| Odds ratio, group 1 over group 2 | 0.425 | 0.313 | 0.577 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Velcade, Melphalan and Prednisone (VMP) than on Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | 4.83 | 3.61 | 7.46 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Velcade, Melphalan and Prednisone (VMP) | Participants received Velcade (bortezomib) 1.3 milligrams per square meter (mg/m\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9. Each treatment cycle was of 6 weeks. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group \[IMWG\] criteria). After implementation of Amendment 7, post interim overall survival (OS) analysis, sponsor confirmation of disease progression was no longer required prior to initiation of subsequent anti-myeloma therapy, except for participants who progressed on VMP arm and requested subsequent therapy with daratumumab. | 117 | 354 | EG000 |
| Group 2 | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Participants received Velcade 1.3 mg/m\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). | 186 | 346 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All cause mortality: From randomization (Day -3) up to 8.3 years; Serious and Other AEs: From start of treatment (Day 1) up to 30 days after last dose of study treatment (up to 8.2 years)
Source ClinicalTrials.gov
Trial
- Title
- A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma
- NCT number
- NCT02195479
- Phases
- PHASE3
- Conditions
- Multiple Myeloma
- Interventions
- Velcade, Melphalan, Prednisone, Daratumumab IV, Dexamethasone, Daratumumab SC
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2018-12-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02195479?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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